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IRCT20221016056192N1 IRCT 2022-10-27 Tehran University of Medical Sciences A comparison of one burr hole vs two burr holes surgery in recurrence of chronic subdural hematoma A comparison of one burr hole vs two burr holes surgery in recurrence of chronic subdural hematoma 2022-11-06 anticipated 40 Complete https://irct.ir/trial/66394 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Random lists of patient allocation will be based on random blocks of 4, 6 and 8. The allocation would be concealed by the randomizer and the person in charge of randomization wouldn't be aware of the treatment they groups would receive. We will generate these random blocks using www.sealedenvelope.com. (Sealed Envelope Ltd. 2022. Create a blocked randomisation list. [Online] Available from: https://www.sealedenvelope.com/simple-randomiser/v1/lists), Blinding description: In this study, we want to investigate two different surgical procedures and since the patients and their relatives will receive a complete description of possible interventions in this study, blinding the patients wouldn't be possible. The patients will have the same number of scalp incisions and scars as the number of burr holes used and that's why they can't be blinded. This is also true for outcome assessors as they can also become aware of allocated groups. Those who'll be performing the procedure would become aware of it and they can't be blinded too. So, in this study only those who analyze and manage the data can be and will be blinded to the allocation. N/A chronic subdural hematoma in brain. Intervention 1: Intervention group: patients who will undergo one bur hole method surgery. patients will go under general anesthesia in both groups. in the supine position, superior to the superior temporal line, an incision will make. after preparing the skull bone, one bur hole will prepare by the perforator. after coagulation and opening of the dura and exiting of SDH fluid, we will irrigate into the hole with warm 37-degree sterile normal saline serum with a syringe until the exiting fluid is clear. a subperiosteal drain will be fixed. the small incision will be sutured by a 2-0 nylon thread. the drain will be equal to the level of the patient's head. Intervention 2: Control group: patients who will undergone two bur hole method surgery. all the steps will be the same as intervention group but instead of one incision, two incision will made superior to superior temporal line and one bur hole in each will be prepared. irrigation will be done from both holes. in the end, similar to other group, one drain will be fix in anterior incision. Yes - There is a plan to make this available What will be shared: Data will contain age, sex, surgery method, time of recurs, blood loss, primary symptoms and brain CT features. whole data will be shared after identified process was done. When: data files will be available one month after publication. To whom: Data will be available for people working in academic institutes . Conditions: data will be shared for whom doing studies about outcomes of cSDH surgery to improve or describe methods of surgery. Where to obtain: all people working in academic institutes can contact E-mail address below : faramarzroohollahi@yahoo.com How to obtain: after receiving E-mail for accessing file of data, we will respond in less than 48 hours. Comments:
public Faramarz Roohollahi
Shariati hospital, Kargar Shomali
Tehran Iran (Islamic Republic of) 1411713135 +98 21 8800 6684 faramarzroohollahi@yahoo.com Tehran University of Medical Sciences scientific Faramarz Roohollahi
Shariati hospital, Kargar Shomali
Tehran Iran (Islamic Republic of) 1411713135 00892188006684 faramarzroohollahi@yahoo.com Tehran University of Medical Sciences Iran (Islamic Republic of) male or female patients more than 18 years old a minimum of 5 mm shift in brain CT scan obvious pressure effect on cortex underlying hematoma clinical symptoms justifiable to hematoma 18 years no limit Both pregnancy period breastfeeding period Sepsis active psychological disorders second surgery in first 48 hours because of technical issues patients who will not attend for follow up history of CSF diversion surgery empyema I62.03 Nontraumatic chronic subdural hemorrhage Treatment - Surgery Treatment - Surgery Intervention group: patients who will undergo one bur hole method surgery. patients will go under general anesthesia in both groups. in the supine position, superior to the superior temporal line, an incision will make. after preparing the skull bone, one bur hole will prepare by the perforator. after coagulation and opening of the dura and exiting of SDH fluid, we will irrigate into the hole with warm 37-degree sterile normal saline serum with a syringe until the exiting fluid is clear. a subperiosteal drain will be fixed. the small incision will be sutured by a 2-0 nylon thread. the drain will be equal to the level of the patient's head. Control group: patients who will undergone two bur hole method surgery. all the steps will be the same as intervention group but instead of one incision, two incision will made superior to superior temporal line and one bur hole in each will be prepared. irrigation will be done from both holes. in the end, similar to other group, one drain will be fix in anterior incision. Recurrence outcome explained as incidence new deficits or exacerbation of clinical condition of patient any time after 48 hours to 6 months of surgery which will confirm with new brain CT scan revealing new hematoma. Timepoint: 1 month and 6 month since surgery. Method of measurement: patients must attend to clinic for check up after 1 month and 6 month of surgery.. if there was neurological deficit CT will be done and recurrence will be assesd. Tehran University of Medical Sciences Approved 2022-07-04 shariati hospital ethics committe,tehran university of medical scince kargar shomali sreet Tehran Tehran Iran (Islamic Republic of)